Reported Aug 2, 2023 · Ongoing
FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA,…
Microvention Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MICROVENTION INC. · 35 Enterprise · Aliso Viejo, CA · 92656
Is this the product you have?
- FRED Flow Re-Direction Endoluminal Device
- REF
FRED3507-PMAFRED3511FRED3511-PMAFRED3516-CAFRED3516-PMAFRED3524FRED3524-CAFRED3524-PMAFRED3536-CAFRED3536-PMAFRED4007-PMAFRED4012-CAFRED4012-PMAFRED4017-PMAFRED4026FRED4026-PMAFRED4038-PMAFRED4508FRED4508-PMAFRED4513-PMAFRED4518-PMAFRED4528FRED4528-PMAFRED4539FRED4539-CAFRED4539-PMAFRED5009FRED5009-PMAFRED5014-PMAFRED5019-PMAFRED5029FRED5029-CAFRED5029-PMAFRED5514-CAFRED5514-PMAFRED5526-CAFRED5526-PMAMV-F351127MV-F352427MV-F401227MV-F401727MV-F451327MV-F500927MV-F501427MV-F501927MV-F552627
- Lot codes and dates
Devices manufactured between June 12020and September 292020
- REF/UDI/Lot
344 of 344 codes
FRED3507-PMA/00842429106655/20070355620070654P20072255L20072255N20073056A20073056B20080759920081453X20082656F20082656G20082852H20083152EFRED3511/20073054C20091654Z200917511FRED3511-PMA/00842429106662/20070754K20071656220072157320072252J20072255P20072255Q20080851B20082656H20082656J20090152RFRED3516-CA/20081154UFRED3516-PMA/00842429106679/20070654Q20071656320072158F20073155520080354B20081154WFRED3524/00811425020982/20070255320070656320071557U20072056320081955R20091654T20091857N20092357XFRED3524-CA/200924555FRED3524-PMA/00842429106686/20071656420071656520072255U20072255V2007225AZ20073056C20073056Q20073056R20080459V20080558E20080853W2008115AC20081255W20081354Q20090956420090956520090966420091558Z20092156J
- Amount recalled
- 474
Where it was sold
Why it was recalled
Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended.
This product could cause temporary or reversible health problems — stop using it.
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